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Trodelvy® Demonstrates Clinical Benefit for Black Patients Consistent with Full Metastatic Triple-Negative Breast Cancer Population in ASCENT Study

Disparities, Such as Access to Healthcare, Comorbidities and Differences in TNBC Disease Biology Typically Drive Worse Clinical Outcomes in Black Women

Excerpt from the Press Release:

FOSTER CITY, Calif.–(BUSINESS WIRE)–Dec. 10, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the Phase 3 ASCENT study evaluating Trodelvy® (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In this subgroup analysis of Black patients, Trodelvy improved progression-free survival (PFS), with a 56% reduction in the risk of disease worsening or death (HR: 0.44; 95% CI: 0.24-0.80; P=0.008) and a median PFS of 5.4 months (n=28) versus 2.2 months with chemotherapy (n=34). Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician’s choice of chemotherapy (HR: 0.64; 95% CI: 0.34-1.19; P=0.159). The results were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) (Poster #P5-16-07).

“Black women are almost three times more likely to be diagnosed with TNBC and may experience worse clinical outcomes compared with white women,” said Lisa Carey, MD, Medical Director of the UNC Breast Center, the Physician-in-Chief of the North Carolina Cancer Hospital and Associate Director of Clinical Research at UNC Lineberger Comprehensive Cancer Center. “This inequality is driven by comorbidities, differences in TNBC biology and other health disparities, which is why understanding how sacituzumab govitecan can work in these patients is so critical. This analysis of the Phase 3 ASCENT study confirms that sacituzumab govitecan delivered the same clinical benefit for Black women as the overall population in second-line locally advanced or metastatic TNBC.”

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. Black women have three times the risk of TNBC as white women, and a 42% higher mortality rate from breast cancer overall. The five-year survival rate for this sub-type of breast cancer is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease.

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